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Trial record 2 of 5 for:    quetant

Multi-elemental Imaging of Lung Tissues With LIBS (Laser-induced Breakdown Spectroscopy) (MEDICO-LIBS)

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ClinicalTrials.gov Identifier: NCT03901196
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:
Evaluate the feasibility of performing a multi-elemental imaging analysis of lung specimens from patients with ILDs, with an technology named LIBS (Laser Induced-Breakdown Spectroscopy)

Condition or disease Intervention/treatment
Interstitial Lung Disease Sarcoidosis Idiopathic Pulmonary Fibrosis Diagnostic Test: Elemental analysis

Detailed Description:

There is a major health problem due to the environmental and occupational related exposures to mineral particles, metals, and dust. The impact on health is considerable in terms of prevalence, morbidity and healthcare costs. Pathologists rarely report the presence of a possible mineral or metal-related etiology in a specimen by lack of available and convenient technology. Therefore, several respiratory diseases are considered idiopathic.

Interstitial lung disease (ILD), also known as diffuse parenchymal lung disease (DPLD) is a group of lung diseases affecting the interstitium (the tissue and space around the air sacs of the lungs). In France, 15.000 new cases of ILD are diagnosed each year. ILD may be classified according to the cause. Idiopathic ILD are ILD of unknown causes. The most frequent idiopathic ILD are sarcoidosis and idiopathic pulmonary fibrosis (IPF).These two diseases are the core topic of the present study since they may relate to important mineral or metal exposure.

The overall goal of this MEDICO-LIBS study is to evaluate the feasibility of using a laser-induced breakdown spectroscopy (LIBS)-based instrument to image(ie, identify, localize and possibly quantify) metals within selected human specimens with ILDs.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Multi-elemental Imaging of Lung Tissues With LIBS (Laser-induced Breakdown Spectroscopy) : a Feasibility Study
Actual Study Start Date : May 16, 2019
Estimated Primary Completion Date : May 15, 2022
Estimated Study Completion Date : May 15, 2023


Group/Cohort Intervention/treatment
Interstitial Lung Disease
Ex : sarcoidosis, IPF
Diagnostic Test: Elemental analysis
LIBS multi elemental analysis of the specimen




Primary Outcome Measures :
  1. Generation of multi-elemental images in tissues with LIBS [ Time Frame: Within a month after reception of the biopsy by the analytical laboratory ]
    Evaluation of the feasibility of collecting and describing LIBS multi-elemental images of lung specimens originating from patients with ILDs


Secondary Outcome Measures :
  1. Description of elemental distribution in the specimens [ Time Frame: Within a month after reception of the biopsy by the analytical laboratory ]
    Comprehensive chemical characterization of both endogenous and exogenous elements for each specimen

  2. Interpretation of the elemental maps [ Time Frame: Within a month after reception of the biopsy by the analytical laboratory ]
    Understanding of the elemental distribution according to the clinical data

  3. Comparison of the elemental distributions with results of other mineralogical investigations [ Time Frame: Within a month after reception of the biopsy by the analytical laboratory ]
    Only for patients who previously benefited from other mineralogical investigations (eg, SEM-EDX), comparison of mineralogical analysis obtained with the elemental distributions obtained with LIBS



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with Interstitial Lung Disease
Criteria

Inclusion Criteria:

  • Patient with ILD
  • Patient informed, and agreed to participate

Exclusion Criteria:

  • Patient opposed to participating in the study.
  • Patient without available specimen.
  • Patient under legal protection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03901196


Contacts
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Contact: Benoit Busser, PharmD, PhD +33 4 76 76 89 39 bbusser@chu-grenoble.fr

Locations
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France
Grenoble Alpes University Hospital Recruiting
Grenoble, France, 38043
Contact: Vincent Bonneterre, MD, PhD       VBonneterre@chu-grenoble.fr   
Contact: Sébastien Quetant, MD       SQuetant@chu-grenoble.fr   
CHRU de LILLE Not yet recruiting
Lille, France, 59000
Contact: Cecile Chenivesse, MD, PhD       cecile.chenivesse@chru-lille.fr   
CHU de Lyon HCL - GH Sud Not yet recruiting
Lyon, France, 69310
Contact: Nathalie Freymond, MD       nathalie.freymond@chu-lyon.fr   
Hôpital Louis Pradel Not yet recruiting
Lyon, France, 69677
Contact: Vincent Cottin, MD, PhD       vincent.cottin@chu-lyon.fr   
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Benoit Busser, PharmD, PhD Grenoble Alpes University Hospital

Publications of Results:
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03901196    
Other Study ID Numbers: 38RC18.134
2019-A00070-57 ( Other Identifier: ID RCB )
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Grenoble:
Laser Induced Breakdown Spectroscopy
Multi elemental imaging
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Lung Diseases, Interstitial
Sarcoidosis
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lymphoproliferative Disorders
Lymphatic Diseases